Country Approval Specialist

Overview

Country Approval Specialist responsible for preparing, coordinating, and maintaining local regulatory and ethics submissions for clinical studies in Argentina.

What you'll do

• Prepare, review, and coordinate local regulatory submissions.
• Provide local regulatory strategy advice to internal clients.
• Coordinate site initiation and submission-related activities with internal teams.
• Act as the country contact for ethics and regulatory submission activities.
• Maintain trial status information in tracking databases.
• Set up and maintain country study files and filing processes.
• Support feasibility activities and regulatory compliance review packages.

What you'll need

• Bachelor's degree or equivalent relevant qualification.
• 2+ years of comparable experience.
• Knowledge of applicable national regulatory guidelines and ethics committee regulations.
• Strong written and oral communication skills.
• Strong attention to detail and documentation quality.
• English language and grammar skills.
• Basic medical terminology knowledge.

Details

• Remote in Argentina.
• Standard Monday-Friday schedule.
• Work may involve office, laboratory, or clinical environments.